FOLFOX6 Totally Neoadjuvant Chemoradiation Therapy in Locally Advanced Rectal Cancer: A Real World Study

Inclusion Criteria:

* Diagnosis of adenocarcinoma of the rectum
* Age: 18-70 years old
* Signed informed consent; able to comply with study and/or follow- up procedures
* Stage of the primary tumor may be determined by ultrasound or MRI
* Stage II (T3-4, N0 \[N0 is defined as all imaged lymph nodes \< 1.0 cm\]) OR stage III (T1-4, N1-2 \[with the definition of a clinically positive lymph node being any node ≥ 1.0 cm\]
* Tumor palpable by digital rectal exam OR accessible by proctoscope or sigmoidoscope
* Distal border of the tumor must be located \< 12 cm from the anal verge
* Tumor amenable to curative resection
* Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
* Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet count ≥ 100 x109/ L, hemoglobin (Hb) ≥ 9g/ dL.
* Total bilirubin ≤1.5 x the upper limit of normal (ULN).
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
* Alkaline phosphatase limit ≤ 5x ULN.
* Amylase and lipase ≤ 1.5 x the ULN.
* Serum creatinine ≤ 1.5 x the ULN.
* Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min.
* No renal disease that would preclude study treatment or follow-up
* ECOG status: 0～1

Exclusion Criteria:

* Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
* No More than 4 weeks since prior participation in any investigational drug study
* More than 4 weeks since prior participation in any investigational drug study
* Clear indication of involvement of the pelvic side walls by imaging
* With distant metastasis
* History of invasive rectal malignancy, regardless of disease-free interval
* Fertile patients must use effective contraception
* Uncontrolled hypertension
* Cardiovascular disease that would preclude study treatment or follow-up
* Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding
* Synchronous colon cancer
* Pregnant or nursing, Fertile patients do not use effective contraception
* Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
* No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
* patients refused to signed informed consent.